Kornimate/medical-research-clean huggingface dataset:
a study of talquetamab and teclistamab each in combination with a programmed cell death receptor-1 (pd-1) inhibitor for the treatment of participants with relapsed or refractory multiple myeloma

Conditions: Relapsed/ Refractory Multiple Myeloma

Summary: the purpose of the study is to identify the safe dose(s) of a pd-1 inhibitor in combination with talquetamab or teclistamab, and to characterize the safety and tolerability of talquetamab or teclistamab when administered in combination with a pd-1 inhibitor.


Eligibility criteria:
inclusion criteria: * have documented initial diagnosis of multiple myeloma according to international myeloma working group (imwg) diagnostic criteria * participants with relapsed or refractory disease that are not a candidate for available therapy with established clinical benefit * have measurable disease at screening as defined by at least 1 of the following: a) serum m-protein level greater than or equal to (\>=) 0.5 grams per deciliter (g/dl); b) urine m-protein level \>= 200 milligrams (mg) per 24 hours; c) light chain multiple myeloma: serum immunoglobulin (ig) free light chain (flc) \>= 10 milligrams/deciliter (mg/dl) and abnormal serum ig kappa lambda flc ratio * have an eastern cooperative oncology group (ecog) performance status score of 0 or 1 exclusion criteria: * prior antitumor therapy within 21 days prior to the first dose of study treatment (proteasome inhibitor \[pi\] therapy or radiotherapy within 14 days, immunomodulatory drug (imid) agent therapy within 7 days, gene -modified adoptive cell therapy or autologous stem cell transplant within 3 months) * prior therapy with pd-1 inhibitors, allogeneic stem cell transplant or solid organ transplant * active plasma cell leukemia, waldenstrom's macroglobulinemia, poems syndrome (polyneuropathy, organomegaly, endocrinopathy, m-protein, and skin changes), or primary light chain amyloidosis * active central nervous system (cns) involvement or exhibition of clinical signs of meningeal involvement of multiple myeloma. if either is suspected, brain magnetic resonance imaging (mri) and lumbar cytology are required * live, attenuated vaccine within 4 weeks before the first dose of study treatment * non-hematologic toxicity from prior anticancer therapy that has not resolved to baseline levels or to grade less than or equal to (\<=) 1 (except alopecia \[any grade\] or peripheral neuropathy to grade \<= 2) * received a cumulative dose of corticosteroids equivalent to \>= 140 milligrams (mg) of prednisone within the 14-day period before the start of study treatment administration
strength and balance in gender- and age-matched controls

Conditions: Healthy Volunteers

Summary: the purpose of this study is to learn more about balance and strength in an elderly population (60 and older). data will be compared between controls and the age/gender- matched pd participants in study "the effects of vitamin d on balance in parkinson's disease" (ohsu irb # 6482). specifically a t-test will be used to compare total work and total power on leg extension and flexion, composite sot score conditions 1-3 and 4-6, response strength and latency on mct, and turn duration from the imobility between the two groups.

inclusion criteria: * over the age of 59 * gender and age-matched (within 3 years) of main protocol participants exclusion criteria: * parkinson's disease diagnosis * significant cognitive deficits. * another neurological or orthopedic deficit that in the investigator's opinion would have a significant impact on gait and cognition (e.g. stroke, fracture). this study involves one visit to oregon health \& science university. the study visit will last approximately 2 hours. measurements: 1. the participant's balance will be assessed by having them stand on a platform and completing mental tasks such as naming the alphabet backwards. they will be asked to have their eyes open on some tasks and closed on other tasks. for safety, they will wear a harness like those used by rock climbers. 2. the participant's ability to move and balance will be measured by putting six sensors on their bodies (both wrists, both ankles, chest, and back). each sensor is about the size and weight of a deck of cards. to measure movement and balance, participants will rise from a chair, walk three feet, turn around, walk back to the chair, and sit down. 3. the participant's strength will be evaluated using a machine that resembles a stationary exercise bike. they will have one leg and foot strapped onto the machine. participants will then be asked to flex and extend their leg as quickly as possible five times. this will be repeated with the other leg.

Eligibility criteria:
inclusion criteria: * over the age of 59 * gender and age-matched (within 3 years) of main protocol participants exclusion criteria: * parkinson's disease diagnosis * significant cognitive deficits. * another neurological or orthopedic deficit that in the investigator's opinion would have a significant impact on gait and cognition (e.g. stroke, fracture).

Keywords: healthy volunteers
the effect of phototherapy on pruritus of patients with chronic kidney disease

Conditions: Uremic Pruritus

Summary: the purpose of this study was to confirm the efficacy of nb uvb phototherapy in alleviating uremic pruritus and investigate the association between improvement of pruritus and change of serum parameters, including routine biochemical data, immune profile and dialysis adequacy.

we would conduct a randomized study to evaluate the effect of nb uvb therapy on uremic pruritus. the intensity of pruritus will be evaluated using visual analog scale (vas) score (0 \[no pruritus\]-10 most severe pruritus\]) and a detailed questionnaire assessing various characteristics of pruritus at baseline . the patients with the intensity of pruritus vas score more than 5 will be randomized to narrow band uvb and control group. phototherapy was administered to the whole body surface 2-3 sessions per week for total 18 sessions in a uv irradiation cubicle. the dose increased from 210mj/cm2 .doses were increased by 10 % at every session. the control group received time-matched exposures to long-wave ultraviolet light. the investigator will determine the pruritic intensity at baseline every 3 sessions by vas score and by detailed questionnaire at baseline and after 18 sessions. the blood sample will also be collected at baseline and after treatment to determine factors associated with improvement.

Eligibility criteria:
inclusion criteria: * chronic kidney disease with moderate to severe uremic pruritus for longer than 2 months exclusion criteria: * pregnancy history of photosensitivity photo-aggravated disease
the effect of the mode of delivery to the pelvic floor function

Conditions: Incontinence; Pelvic Organ Prolapse

Summary: the childbirth is one of the risk factors for pelvic organ prolapse. in order to prevent the pelvic organ prolapse, the physicians do not routinely advice any exercises after deliveries. the investigators wondered if the mode of deliveries such as ceserean section, vaginal route delivery with episiotomy or vaginal route delivery without episiotomy effect the pelvic floor function differently or not. in order to evaluate this, the investigators are planning to measure the muscle tonus in primiparous women.


Eligibility criteria:
inclusion criteria: * primiparous women 5-10 years after birth exclusion criteria: * multiparous women women with connective tissue disorders

Keywords: pelvic organ prolapse
assessing benefits of niraf detection for identifying parathyroid glands during total thyroidectomy.

Conditions: Postoperative Hypoparathyroidism; Thyroid Neoplasms; Thyroid Cancer

Summary: this study describes a single center, randomized, single-blinded clinical trial to assess the clinical benefits of the use of near infrared autofluorescence (niraf) detection with an fda-cleared device 'parathyroid eye (pteye)' for identifying parathyroid glands (pgs) during total thyroidectomy (ttx). it compares risk-benefits and outcomes in ttx patients where niraf detection with pteye for parathyroid identification is either used or not used.

inadvertent damage or excision of a healthy parathyroid gland (pg) following a total thyroidectomy (ttx) could result in transient hypocalcemia (\ 6 months) in 7% of the patients (1, 2). in both of these circumstances, patients would require calcium and active vitamin d supplementation in addition to a potentially prolonged hospital stay and/or unplanned hospital readmission adding to unnecessary burden and healthcare costs. these complications could be minimized with label-free intraoperative pg identification using near infrared autofluorescence (niraf) detection with a fiber-probe based approach (3 - 5) as utilized in 'pteye', which is medical device that was recently fda-cleared (6). however, the true impact of this particular niraf-based approach on patient outcomes is yet to be determined the aim of this prospective single blinded randomized study is to compare 2 groups of patients: ttx patients operated using niraf detection technology with pteye as adjunct tool (niraf+) vs. patients operated without the adjunct technology (niraf-). the main objective of this study is to assess the benefit of intraoperative use of niraf detection technology via pteye during ttx procedures with regard to postoperative hypocalcemia, pg identification, pg auto-transplantation and inadvertent resection rates compared to standard of care.

Eligibility criteria:
inclusion criteria: (i) all patients eligible for total thyroidectomy (ttx), with or without lymph node dissection. (includes patients undergoing a ttx who have undergone a prior neck exploration for parathyroid disease or other but have an intact thyroid). (ii) all patients undergoing completion thyroidectomy. exclusion criteria: (i) patients with concurrent parathyroid disease. (ii) patients with incidental enlarged parathyroid discovered during ttx. (iii) patients undergoing thyroid lobectomy/partial thyroidectomy.

Keywords: total thyroidectomy intraoperative parathyroid identification near infrared autofluorescence postoperative hypocalcemia postoperative hypoparathyroidism
neuromuscular electrical stimulation on median nerve facilitates low motor cortex excitability in human with spinocerebellar ataxia

Conditions: Spinocerebellar Ataxia

Summary: spinocerebellar ataxia (sca) is a hereditary disorder with movement incoordination. the ataxia performed low intra-cortical facilitation mainly due to the degenerative cerebellum. noninvasive sensory stimulations such as peripheral electrical stimulation were reported to modulate the excitability of the motor excitability. neuromuscular electrical stimulation (nmes) was proposed as a neuromodulation tool for the aberrant motor excitability on the sca. this study aims to investigate the effect of nmes on the motor excitability in the sca, and the differentiation on the central or peripheral motor excitability changed by the nmes.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of spinocerebellar ataxia * no history of epilepsy * no other neuromuscular disorder * no fracture within the last six months and restricted movement on the upper extremity * limited trembling hand allowed for the emg recording.

Keywords: spinocerebellar ataxia (sca) motor evoked potential (mep) neuromuscular electrical stimulation (nmes) silent period cerebellum
kochujang, a fermented soybean-based red pepper paste, decreases visceral fat and improves blood lipid profiles in overweight adults

Conditions: Overweight

Summary: with the epidemic of obesity and diabetes growing around the world, kochujang (kcj) may be potentially effective in preventing and treating obesity and cardiovascular risks if proven in humans. however, human trial still have not been reported with kcj supplementation. in the present study, we investigated the hypothesis that kcj supplementation can be decrease the body fat and improve blood lipid profiles in overweight adults.

the aim of this study was to evaluate the efficacy of kcj supplementation on anthropometric parameters, visceral fat/subcutaneous fat, and blood lipid profiles in overweight subjects. sixty overweight subjects with bmi \>25 kg/m2 and waist-hip-ratio (whr) ≥ 0.90 for men and ≥ 0.85 for women were randomly assigned to either kcj supplement (n=30, 32 g/day) or placebo (n=30, 32 g/day) group for 12 weeks.

Eligibility criteria:
inclusion criteria: * bmi \>25kg/m2 and 2)waist-hip ratio (whr): whr\> 0.90(male), whr\>0.85(female) exclusion criteria: * lipid metabolic disorders * \>10% changes in body weight in the past 3 months * cardiovascular disease such as arrhythmia, heart failure, myocardial infarction, and wearing pacemaker * allergy or hypersensitivity to any of the ingredients in the test products - history of reaction to any of the experimental products or of gastrointestinal diseases such as crohn's disease or gastrointestinal surgery * participation in other clinical trials within the past 2 months * abnormal hepatic liver function, renal disease such as acute * chronic renal failure, nephrotic syndrome * use of anti-psychosis drug therapy within 2 months * laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study * history of alcohol or substance abuse * pregnancy or breastfeeding

Keywords: kochujang, visceral fat population
ai-guided stress management breathing practices via a wearable device

Conditions: Stress Reduction

Summary: this study explores the effectiveness of ai-guided breathing practices for stress management in adults. in this randomized controlled trial, 120 participants will be recruited and assigned to an intervention group (n=90) or a control group (n=30). the study includes four brief breathing practices, guided by a wristband. the intervention group will interact with an ai chatbot to receive a personalized daily breathing plan for 28 days, adjusted weekly based on feedback. meanwhile, the control group will practice progressive muscle relaxation daily. it is hypothesized that, the intervention group will have significantly improvements in stress management and emotion regulation skills compare to the control group. these group differences are expected to persist at 1-month, 3-month and 6-month follow-up assessment.


Eligibility criteria:
inclusion criteria: 1. currently enrolled college students. 2. aged between 18 and 30 years old. exclusion criteria: 1. current or past history of psychotic disorders. 2. using contraceptives, cortisol, beta-blockers, antidepressants, or other psychiatric medications, as well as medications for chronic diseases during the intervention and follow-up periods.

Keywords: stress reduction breathing practices wearable device ai guided intervention
evaluation of colonic diminutive polyps with electronic filters

Conditions: Colonic Polyps

Summary: diminutive polyps, measuring between 1 and 5 mm, represent the vast majority of colorectal polyps encountered during colonoscopy. since the chance of harboring advanced adenoma or carcinoma in this kind of polyps is very low, a "remove and discard" technique has been proposed. the differentiation between adenoma/non adenoma polyps is based on the use of endoscopes equipped with high definition, magnification and optical filters.

any diminutive polyps encountered during a colonoscopy will be examined with the use of electronic filters and magnification and assigned by the endoscopist to a adenoma/non adenoma category, resected and retrieved: a follow up surveillance period will be assigned on the basis of the endoscopic appearance of the polyps. each polyp will then be sent separately to pathology for the histologic evaluation, and a surveillance interval period will be determined accordingly.

Eligibility criteria:
inclusion criteria: * all subjects undergoing colonoscopy exclusion criteria: * patients assuming oral anticoagulant therapy
post operative quality of life and pain in ankle fractures: cast versus functional treatment

Conditions: Ankle Fractures

Summary: rationale: ankle fractures are common traumatic lesions. in order to restore the anatomical situation of the ankle joint to prevent posttraumatic arthritis, these fractures often need surgical treatment. both cast immobilisation and functional treatment have proved to be reliable postoperative treatment regimes. insight into the quality of life and the level of pain is necessary to determine if these treatments can be related to higher patient satisfaction and earlier resumption of daily activities and work. objective: the aim of this study is to examine two postoperative treatments for surgically corrected ankle fractures. postoperative, direct functional mobilisation is compared to short term plaster cast fixation. the focus of this study is on quality of life, pain and the use of pain medication, and resumption of work and daily activities. main study parameters/endpoints: quality of life, function, pain, swelling, daily activities and work, disabilities (pain disability index), complications


Eligibility criteria:
inclusion criteria: * age 18-65 at the time of surgery * ankle fractures needing operative correction * weber type b or c, lauge hansen type supination-adduction, supination-external rotation and pronation-external rotation * closed fractures * postoperative stable for exercise * operated at the university medical centre st radboud, nijmegen or alysis zorggroep, rijnstate hospital, arnhem exclusion criteria: * open fractures * fractures with complete dislocation of the ankle joint * body mass index \> 30 * previous ankle fracture on the affected side * concomitant traumatic injuries reducing the ability for postoperative mobilization * pre-existent use of pain medication, medication affecting fracture- and wound healing * postoperative unstable for exercise * co-morbidity: pain syndromes, fontaine iib, iii and iv, symptomatic venous insufficiency, auto-immune disorders, rheumatic arthritis
early cpap in covid-19 patients with respiratory failure.

Conditions: CPAP Ventilation; COVID-19; Emergency Departments

Summary: the study aims at clarifying whether early treatment with continuous positive airway pressure (cpap) ventilation is able to reduce the need for intubation or death in patients visiting an emergency department (ed) with known or suspected covid-19 infection and insufficiency respiratory.

eligible patients will be randomized to two treatment arms: current clinical practice (control arm) and early treatment with cpap in addition to current clinical practice (experimental arm). to deal with the current emergency situation, the study will adopt an adaptive design with a bayesian continuous monitoring. such design allows to stop the study as soon as the data provide sufficient evidence of efficacy or ineffectiveness of the studied treatment. the primary endpoint of the study is the combination of intubation or death within 7 days of randomization. the secondary endpoint is 30-day mortality. all patients arriving at the ed will be evaluated to verify the presence of inclusion and exclusion criteria. randomization will be performed through an ad-hoc electronic case report form (ecrf). eligible patients should be randomized as soon as possible, possibly immediately after the ed triage. patients randomized to the control arm will be treated according to current clinical practice, which currently does not involve the use of cpap. therefore, these patients should not start treatment with cpap immediately after randomization. cpap treatment, however, is allowed at a later stage, if deemed appropriate according to clinical judgment. patients randomized to the experimental arm should begin treatment with cpap as soon as possible. cpap should only be performed with a helmet, using a positive end-expiratory pressure (peep) between 8 and 14 cmh2o and an inspired oxygen fraction (fio2) between 40 and 60%. fio2 and peep must be modulated, within the limits indicated above, so as to obtain a saturation \> 94%. whenever this goal cannot be achieved, the patient should be referred to the intensivist.

Eligibility criteria:
inclusion criteria: ed patients positive to or suspected of covid-19 infection with at least one of the following symptoms: * fever * cough/dyspnea * respiratory symptoms or ed arrival for respiratory reason and for whom there are the following conditions: * spo2 \< 95% in ambient air or positive quick walk test * pao2/fio2 \> 200 in ambient air or with venturi mask, evaluated in 1 hour from ed arrival. exclusion criteria: * bpco patients * age \> 70 years * pregnant status * contraindications for cpap
safety and immunogenicity study of gx-70 in tb patient

Conditions: Pulmonary Tuberculoses; High Risk Factors for Relapse; Treatment Failure

Summary: the purpose of this study is to determine the safety, tolerability, and immunogenicity in patients with pulmonary tuberculosis of an investigational dna vaccine being developed for the prevention of relapse of tuberculosis.

tuberculosis still matters in domestic as well as global public health. according to who, 8,700,000 cases of tuberculosis occured in 2011, and 1,400,000 of them resulted dead. tuberculosis patients with the cavity and positive on afb show high rate of relapse and treatment failure. those with high risk of relapse and treatment failure may need more effective treatment before acquiring resistance and infecting others. gx-70, which consists of the four-antigen plasmids from mtb together with recombinant flt3 ligand is an investigational dna vaccine designed to prevent relapse or treatment failure. the purpose of this study is to assess safety of gx-70, in pulmonary tb patients with high risk factors for treatment failure or relapse.

Eligibility criteria:
inclusion criteria: 1. subjects who voluntarily consented, after listening enough explanation for this study and investigational product. 2. adults between 19 and 65 years. 3. tb patients without a history of tb diagnosis, who show positive on both afb smear and tb-pcr 4. tb patients who satisfy following conditions: cavity spotted from chest imaging before tb therapy, positive on afb smear 2 months after tb therapy. exclusion criteria: 1. at 2 months after therapy started, afb smear shows 1+ or higher, but tb pcr shows ntm positive. 2. if positive on afb smear is resulted from dead mtb 3. serious tb such as tuberculous encephalomeningitis 4. patients with serious pulmonary symptom except tb 5. patients show poor vital sign considered to be difficult to participate 6. patients with heart, renal, or liver failure 7. patients with infection, ulcer, edema, tattoo, scar, wound and other conditions in skin around 3cm of deltoid muscle that result inappropriate to inject through electroporation. 8. when thickness of skin around deltoid muscle which is to be injected exceeds 40mm 9. patients with qtc prolongation on 12-lead ecg 10. patients with a cardiac device (such as a pacemaker) 11. patients that the researchers do not think fit into the group, including patients failed in compliance assessment

Keywords: tuberculosis dna vaccine electroporation gx-70